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The goal of this clinical trial is to evaluate the effect of dental anxiety on the success of mandibular anesthesia in patients with symptomatic irreversible pulpitis in mandibular molar teeth.
The main questions it aims to answer are:
Does dental anxiety influence the success rate of inferior alveolar nerve block (IANB)? Is there a correlation between salivary cortisol levels and anesthesia outcomes in anxious patients?
Researchers will compare two groups of patients based on their Modified Dental Anxiety Scale (MDAS) scores:
Low/No anxiety group (MDAS < 10) Moderate to high anxiety group (MDAS ≥ 11, including those with dental phobia)
Participants will:
Rate their pre-treatment pain using the Heft-Parker Visual Analog Scale (HP-VAS) Provide salivary samples for cortisol measurement before and after anesthesia Undergo standardized mandibular anesthesia protocols (IANB and buccal-lingual infiltration) Report pain during treatment using the HP-VAS Undergo monitoring of SpO₂ and pulse via pulse oximetry To control for cortisol fluctuations and circadian rhythm, all procedures and saliva collections will occur between 09:00-12:00. Participants will be asked to avoid food for at least 2 hours prior, and refrain from caffeine, alcohol, smoking, or heavy exercise for at least 24 hours before treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Anxiety Group | Experimental | Participants with Modified Dental Anxiety Scale (MDAS) scores less than 10. |
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| Moderate-High Anxiety Group | Experimental | Participants with MDAS scores of 11 or higher, including those with dental phobia (MDAS > 19). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Mandibular Anesthesia Protocol | Procedure | Participants receive an inferior alveolar nerve block (IANB) using 1.8 ml 4% articaine with 1:100,000 epinephrine (Ultracaine DS Forte) via a 27-gauge dental needle, followed by buccal and lingual infiltration anesthesia after 5 minutes. Topical 10% lidocaine spray is applied prior to injection. All procedures are performed by the same clinician between 09:00-12:00. Salivary cortisol, pulse oximetry, and pain assessments are conducted before and after the anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate of Mandibular Anesthesia | The success of inferior alveolar nerve block (IANB) will be determined based on the patient's pain response during endodontic treatment, measured using the Heft-Parker Visual Analog Scale (HP-VAS). Anesthesia will be considered successful if pain during treatment is rated as "none" or "mild" on HP-VAS. | Within 30 minutes after anesthesia administration, during the endodontic procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Dental Anxiety Level and Anesthesia Success | Relationship between Modified Dental Anxiety Scale (MDAS; score range 5-25, higher scores indicate greater anxiety) and anesthesia success rates during a single endodontic treatment session. | At the end of the single treatment session (within 30 minutes after anesthesia administration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kutahya Health Sciences University Faculty of Dentistry | Kütahya | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2024 | Aug 7, 2025 | Prot_SAP_000.pdf |
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| Salivary Cortisol Level Change | Difference in salivary cortisol levels measured 15 minutes before and 15 minutes after anesthesia to assess stress response related to dental anxiety. | Pre-anesthesia and 15 minutes post-anesthesia |